Patient-Specific Knee Surgery for Osteoarthritis

Recruiting in Palo Alto (17 mi)

Overseen by Edward M Vasarhelyi, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of our study is to determine, using a prospective, randomized-controlled trial, the economic viability and clinical outcomes associated with patient-specific instrumentation (PSI) for total knee arthroplasty in an obese patient population.

Eligibility Criteria

This trial is for English-speaking adults aged 19-70 with obesity (BMI between 30 and 50) who have knee osteoarthritis best treated by total knee replacement. It's not for those with prior open knee surgery, infections, trauma, cognitive issues that affect questionnaire completion, inflammatory joint diseases, plans for bilateral knee replacements at once, fibromyalgia or chronic pain syndrome.

Inclusion Criteria

I have knee pain from arthritis and need a knee replacement.

I am between 20 and 70 years old.

English-speaking

Exclusion Criteria

I have had previous knee surgery, infection, or injury.

I am having or have had knee replacement surgery on both knees at the same time.

I am able to complete questionnaires without any issues.

Participant Groups

The study is testing the economic and clinical effectiveness of Attune TruMatch Personalized Solutions Instruments in performing total knee replacements in obese patients. This involves comparing patient-specific instrumentation to standard methods using a randomized-controlled approach.

Group I: Total Knee Arthroplasty with PSI Experimental Treatment 1 Intervention

Total Knee Replacement with the use of the Attune TruMatch (TM) Patient-Specific Instrumentation

Group II: Total Knee Replacement Active Control 1 Intervention

Total Knee Replacement, as per Standard of Care

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

London Health Sciences Centre, University Hospital London, Canada

Who Is Running the Clinical Trial?

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's Lead Sponsor

Lawson Health Research Institute Lead Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Lead Sponsor

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's Lead Sponsor

DePuy Orthopaedics Industry Sponsor

Johnson & Johnson Medical Companies Industry Sponsor

References